Kornimate/medical-research-clean huggingface dataset:
effects of abnormal respiratory mechanics and assisted mechanical ventilation on neuro-regulation of respiration

Conditions: Neuroregulation of Breathing

Summary: due to recent technological improvements, it is now possible to record the electrical activity of the diaphragm (eadi), a direct expression of the central nervous system respiratory center activity. by providing a relatively easy-to-use technique to record eadi the nava (neurally adjusted ventilatory assist) technology offers a new opportunity to explore the effects of various interventions on neural inspiratory activity in human subjects during spontaneous and assisted ventilation both for normal and simulated abnormal respiratory mechanics. the main aim of this project is to measure and compare the components of eadi signal, the direct reflect of the respiratory centers activity, under various conditions of normal and simulated altered respiratory mechanics (either obstructive or restrictive respiratory mechanics° in order to better understand the neuroregulation of breathing. the second aim of the present project is to perform a similar analysis regarding the effects of various modes (pressure support and nava) and various levels of assisted ventilation both in case of normal and abnormal respiratory mechanics. based on the information recorded on eadi and flow and pressure signals, the last aim of this project is to correlate eadi and pneumatic derived parameters both during spontaneous breathing and assisted ventilation. practically, by using the nava recording technology, the investigators will perform a physiological study on normal volunteers to explore the effects of normal and simulated abnormal respiratory mechanics on eadi, flow and pressure signals (airway, oesophageal and transdiaphragmatic pressures) in order to better understand the neuroregulation of breathing. thirty healthy volunteers with documented normal lung function tests will be included in the study (obstructive respiratory mechanics will be simulated in 15 healthy volunteers and respiratory mechanics will be simulated in 15 healthy volunteers).


Eligibility criteria:
inclusion criteria: * man ; * less than 35 years old ; * non obese (bmi \<30 kg/m2) ; * normal pulmonary function tests (vital capacity and forced expiratory volume in one second in the normal range for the age and size) * no history of respiratory disease (asthma, pneumothorax) ; * no contraindication for nasogastric tube placement exclusion criteria: * active or past respiratory disease ; * contraindication to nasogastric tube placement ; * less than 18 years old; * subject protected by the law (eg subject incapable of discernment, wardship subject, ...) ; * subject not covered by a social security system ; * subject with a subordination relationship with a member of the research team.

Keywords: electrical activity of the diaphragm neuro regulation of breathing abnormal respiratory mechanics assisted mechanical ventilation pressure support neurally adjusted ventilatory assist
psylliumrx dietary fiber study

Conditions: Obesity; Childhood Obesity

Summary: the purpose of this pilot study is to assess the feasibility of a 3-month dietary fiber intervention: 1) engaging adolescents in regularly consuming a dietary fiber preparation (psyllium powder) and obtaining their parents' support, 2) recruit into a clinical pilot trial with liquid meal challenge test to study the metabolic effects of the dietary fiber preparation. a study modification will be submitted to add additional study arms for feasibility (strength training, coaching).

for this 3-month clinical pilot trial to test the effects of dietary fiber, 120 healthy obese adolescents and young adults, age 12-21 (\>97th percentile of bmi-for-age) will be recruited to participate in this study. recruitment outreach will begin with an email invitation. parents will be encouraged to call a toll-free number for study information and answer via email. one email will be sent to potential study participants. if there is no response to the email, research staff will call parents up to 5 times and leave 3 messages to introduce the study. once a parent or potential participant has been reached over the phone, research staff will explain the study and determine interest in participating. if member is interested in participating, research staff will email member the informed consent form (icf). participants will sign icf using adobe e-sign web server. intervention: participants will be instructed to consume 1 tea spoon of psyllium per day for 3 months and otherwise maintain their habitual diet. using a mobile application, participants will be asked to track bowel movement and intestinal symptoms such as bloating and flatulence beginning two weeks prior to the intervention. liquid meal challenge test: the metabolic test will be conducted as two sessions lasting 180 minutes each, before and after the dietary fiber intervention (week 0 and 12). subjects will participate in the metabolic tests after an overnight fast. subjects will consume 250 ml of a standard liquid meal replacement shake with sugar added to 75 g of total sugar per meal (equivalent to oral glucose tolerance test used in clinical care). blood draw will be done through an indwelling catheter in the antecubital vein and blood samples collected into 3 ml ethylenediaminetetraacetic acid (edta) containing tubes at -15, 0, 30, 60, 90, 120, and 180 minutes after administration of the test meal. an additional 5 ml serum tube and urine will be collected at time -15 min. total blood draw volume for the entire test is 26 ml.

Eligibility criteria:
inclusion criteria: * kaiser permanente southern california (kpsc) member for at least 12 months. * kpsc members ages 12 to 21 years old. * kpsc member with \>97th percentile of bmi for age. * minors with parents whose preferred language is english. * 18 to 21 year old members whose preferred language is english. exclusion criteria: * has diagnosis of serious mental illness and/or cognitive impairment. * provider has concerns over participation. * minors with parent whose preferred language is not english. * 18 to 21 year old members whose preferred language is not english.
study in healthy volunteers to investigate the effects of diltiazem on the pharmacokinetics of naloxegol

Conditions: Drug Induced Constipation

Summary: study in healthy volunteers to investigate the effects of diltiazem on the pharmacokinetics of naloxegol.

an open-label, sequential, 3-period study to assess the effects of diltiazem on the pharmacokinetics of naloxegol in healthy subjects

Eligibility criteria:
inclusion criteria: * provision of signed and dated, written informed consent prior to any study-specific procedures. * male and female (nonchildbearing potential, nonlactating) healthy volunteers aged 18 to 55 years inclusive, with suitable veins for cannulation or repeated venipuncture. * female volunteers must have negative pregnancy test (screening and admission), must not be lactating, and must be of nonchildbearing potential, confirmed at screening by being postmenopausal, or documentation of irreversible surgical sterilization not in. * male volunteers should be willing to use barrier contraception ie, condoms, from the first day of dosing until 3 months after dosing with the ip. the female partner should use contraception during this period. * volunteers must have a bmi between 18 and 30 kg/m2, inclusive, and weigh at least 50 kg. exclusion criteria: * any clinically significant disease or disorder (eg, cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine) which, may put the volunteer at risk of participation in the study, or influence of the adme of drugs. * any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of ip. * any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results as judged by the investigator. * significant orthostatic reaction at enrolment, as judged by the investigator. * abnormal vital signs, after 10 minutes supine rest as defined in protocol.

Keywords: phase 1 healthy male and female volunteers drug-drug interaction pharmacokinetics naloxegol
effect of ultrasound cavitation versus electrolipolysis on obese infertile women with polycystic ovarian syndrome

Conditions: Polycystic Ovary Syndrome

Summary: this study aims to determine the difference between the effect of ultrasound cavitation and electrolipolysis on obese infertile women with polycystic ovarian syndrome.

polycystic ovarian syndrome (pcos) is the most prevalent endocrinopathy among women during reproductive age . pcos affects 5-10% of women in reproductive age. it has an effect on quality of life , fertility and pregnancy. obesity plays a significant role in reproductive disorders, particularly in women. it is associated with anovulation, menstrual disorders, infertility, difficulties in assisted reproduction, miscarriage, and adverse pregnancy outcomes. the treatment of obesity and infertility causes some harm to women, due to the danger of some operations and medications other than the high cost of these operations, so it is necessary to use a therapeutic alternative that is non invasive, with lower risk and lower cost. both ultrasound cavitation (uc) and electrolipolysis are non invasive modalities with many positive effects on obesity and pcos outcomes. the effect of both the uc and electrolipolysis has been separately investigated in previous studies. though, no studies were found to compare the effect of both modalities in the management of infertile women with pcos. therefore, this study will be conducted to explore the effect of uc versus electrolipolysis on infertile women with pcos.

Eligibility criteria:
inclusion criteria: * infertile married pcos women, diagnosed by rotterdam criteria . * their ages will be ranged between 25-35 year old. * their bmi will be ranged from 30-40 kg/ m2. * their waist/hip ratio equal to or more than 0.85 exclusion criteria: * thyroid dysfunction (hypothyroidism). * chronic and/or systemic illnesses (e.g. diabetes mellitus, liver, renal respiratory failure and cardiovascular disorders). * malignant tumors. * tubal adhesions as well as uterine abnormalities. * skin diseases in the abdominal and gluteal regions. * conditions that may prevent the use of electrical stimulation.
study of qrh-882260 heptapeptide application in the colon

Conditions: Colon Cancer Prevention

Summary: a phase 1b study of the efficacy of a topically-administered 7-amino acid peptide labeled with a near-infrared fluorophore cy5 for detecting neoplastic areas of the colon is proposed. the study will test the efficacy of administering this agent (qrh-882260 heptapeptide) to human subjects undergoing clinically-indicated colonoscopy for endoscopic resection of known colonic adenomas or for surveillance biopsies of known dysplasia in the setting of irritable bowel disease (ibd). up to 120 evaluable subjects will be enrolled. subjects will be recruited around scheduled standard of care procedures. the endoscopists performing the procedures are all endoscopists credentialed at the university of michigan to do these procedures. urine for dipstick pregnancy testing (if applicable) will be collected before the procedure, along with medical information. vital signs are routinely monitored throughout the clinical procedure and are available in the electronic medical record. the endoscopy will proceed per the university of michigan health system (umhs) standard of care. the endoscopist performing the clinical procedure will evaluate the potential risk (if any) for the subject to continue with the procedure or study. five ml of the reconstituted qrh-882260 heptapeptide (\~100 μm) will be sprayed onto the site of interest through a catheter in the endoscope. five minutes after qrh-882260 heptapeptide application, the unbound peptide will be washed off using the endogator irrigator and the residual liquid will be suctioned. pictures with white-light and fluorescence will be taken with the scanning fiber based molecular imaging endoscopic probe inserted via the instrument channel of the standard endoscope before the qrh-882260 heptapeptide application, immediately after application and then again after the qrh-882260 heptapeptide will be washed off. the area of interest identified will be resected/biopsied per discretion of the endoscopist per clinical care. all specimens taken are for clinical care only (not research use) and will be sent for routine histology per umhs standard of care.


Eligibility criteria:
inclusion criteria: subject meets at least one of the following criteria: * at increased risk for colorectal cancer (crc) and colonic polyps * known colonic adenomas scheduled for colonic resection * scheduled for outpatient colonoscopy for follow up surveillance of ibd with known dysplasia or who are at high risk for high grade dysplasia * subject is scheduled for outpatient colonoscopy in the medical procedures unit at umhs * subject is medically cleared for the procedure (e.g. washout for anticoagulants, co-morbidities) standard practice guidelines for safely proceeding with the procedure will be sufficient for the study * age 18 to 100 years * willing and able to sign informed consent exclusion criteria: subjects with known allergy or negative reaction to cy5 (a near-infrared fluorophore) or derivatives * subjects on active chemotherapy or radiation treatment * pregnant or trying to conceive
validation of prism-5-op, measure of addiction to prescription opioid medication

Conditions: Opioid-Related Disorders; Opiate Addiction; Narcotic Abuse; Drug Abuse

Summary: the purpose is to validate the prism-5-op as a measurement of prescription opioid substance use disorder.

"based on a review of the literature, the food and drug administration (fda) concluded that more data are needed regarding the serious risks of misuse, abuse, addiction, overdose, and death associated with the long-term use of extended release/long acting (er/la) opioid analgesics. thus, the fda is requiring that er/la opioid analgesic drug sponsors conduct post-marketing studies to assess these risks. the present study, pmr study #2065-2, focuses on addiction, and addresses the fda requirement to conduct a validation study of the measure of addiction that will be used in pmr study #2065-1. the primary objective for study 2b is to validate prism-5-op measures of dsm-5 prescription opioid sud/addiction in patients who have, or have had, a prescription for opioids for at least 30 days to treat chronic pain"

Eligibility criteria:
inclusion criteria: 1. has or has had a prescription for opioids for chronic pain for at least 30 days 2. age 18 years or older and english-speaking 3. willing and able to provide informed consent" exclusion criteria: 1. patient has a hearing or vision impairment that would preclude an interview or completion of self-administered questionnaires 2. patient too cognitively impaired to give informed consent or participate in the evaluations.
definitive radiation for high-risk spine metastases

Conditions: Metastatic Cancer; Metastatic Lung Cancer; Metastatic Breast Cancer; Metastatic Tumor; Metastatic Tumor of Bone; Metastatic Tumor to the Spine; Spine Metastases; Metastasis

Summary: this study is looking at whether patients with cancer that has aggressively spread to the spine can be treated with stereotactic body radiation therapy only and avoid a large spine surgery


Eligibility criteria:
eligible patients must have: * any pathologically proven solid tumor diagnosis not of central nervous system origin with radiographic or pathologic evidence of metastatic disease * metastatic spine involvement documented by imaging * involvement of maximum 3 contiguous vertebral bodies at the index site * intact neurologic function, or only minor neurologic deficits with muscle strength greater or equal to 4 out of 5 with or without steroids * an evaluation by an radiation oncology and orthopedic spine/neurosurgery attending * ecog performance status of 0-3 patients are ineligible if they have: * an unstable spine defined as a spinal instability neoplastic score (sins) greater than 12 * had previous surgery or radiation to address the target spinal metastases * radiosensitive tumors (e.g. small cell lung cancer, lymphoma, multiple myeloma, and germ-cell tumors)
radiotherapy of pelvic lymph nodes in high risk prostate cancer - a retrospective analysis

Conditions: Prostatic Neoplasms Benign; Radiotherapy Side Effect; Lymph Node Disease

Summary: men with high risk prostate cancer who underwent radiotherapy of the prostate/seminal vesicles or underwent postoperative radiotherapy including pelvic lymph nodes between 2010 and 2016 are analyzed retrospectively. the aims are to estimate progression-free survival as well as toxicity according to ctcae v4.03.

collection of data and retrospective analysis of patients with high risk prostate cancer treated with radiotherapy to pelvic lymph nodes. what influence has irradiation of pelvic lymph nodes on patients with high risk prostate cancer in terms of progression free survival and toxicity. how does this influence side effects with respect to gastrointestinal (proctitis, abdominal pain, diarrhea) and genitourinary (cystitis, urinary disorders) toxicities (ctcae v4.03)

Eligibility criteria:
inclusion criteria: * men with high risk prostate cancer treated with radiotherapy to prostate/seminal vesicles or postoperative radiotherapy and pelvic lymph nodes at the kantonssptial graubuenden, department of radiation oncology between 2010 and 2016 exclusion criteria: * men with prostate cancer other than high risk disease and no radiotherapy to pelvic lymph nodes
military suicide research consortium

Conditions: Suicidal and Self-injurious Behaviour

Summary: the consortium's overall mission can be summarized as follows; each function is developed with the goal of clear military relevance: 1. produce new scientific knowledge about suicidal behavior in the military that improves mental health outcomes for the investigators men and women in uniform. 2. use high quality research methods and analyses to address problems in policy and practice that have a direct impact on suicide-related and other mental health outcomes for military personnel. 3. disseminate consortium knowledge, information, and findings through a variety of methods appropriate for decision makers, practitioners, and others who are accountable for ensuring the mental health of military personnel. this includes the rapid response function so that queries from decision makers and others to the consortium are answered with speed and efficiency. technical assistance and support for decision makers and others is an integral aspect of this consortium function. this aspect of the consortium will warehouse knowledge about suicidal behavior in general (e.g., from civilian and international sources as well as from military sources), so that military issues can be informed in a comprehensive manner. 4. train future leaders in military suicide research through experience within a multi-disciplinary setting for ph.d. students and postdoctoral scholars interested in research questions on military suicide of both a basic and applied nature.

this is a research consortium responsible for the conduct of a wide range of studies, including clinical trials. all clinical trials funded through the consortium will be registered separately.

Eligibility criteria:
inclusion criteria: * msrc studies are inclusive of all individuals who are eligible as defined by each study's protocol regardless of age, gender, race or ethnicity, socioeconomic status, sexual orientation, and any other demographic characteristics. measures and treatments are translated and culturally adapted to the extent possible. exclusion criteria: * specific to each investigator's protocol.
esophacap for the detection of early esophageal carcinoma

Conditions: Barrett Esophagus; Esophageal Cancer; Gastric Cancer

Summary: this study is to identify potential biomarkers for the early detection of barrett's esophagus, esophageal carcinoma (both adenocarcinoma and squamous cell carcinoma), and gastric cancer via sponge cytology.

this study is to identify potential biomarkers for the early detection of barrett's esophagus, esophageal carcinoma (both adenocarcinoma and squamous cell carcinoma). esophageal and gastric cytology will be collected via sponge capsule. candidate genes will be tested with dna isolated from these samples in order to identify optimal biomarkers to differentiate between barrett's esophagus and esophageal/gastric cancer versus normal esophageal/gastric tissue.

Eligibility criteria:
inclusion criteria: * undergoing esophagogastroduodenoscopy at johns hopkins hospital from 1/2016 to 12/2025 * age greater than 18 years * patients must be able to swallow a capsule exclusion criteria: * patients in either arm with extra-esophageal malignancies including head and neck and gastric cancer * patients who have undergone esophagectomy * patients who have undergone radiation to the chest * patients who are younger than 18 * patients with esophageal stents * patients with esophageal strictures disabling passage of the capsule
endoscopic vs. suction device calibration in sleeve gastrectomy

Conditions: Gastrectomy; Obesity

Summary: this study aims to compare the difference in staple usage and post-operative gerd (heartburn) between patients that had an endoscope used versus patients that had a suction calibration system used on them during "laparoscopic sleeve gastrectomy" (lsg).

there are multiple choices for a surgeon and their patient when it comes to weight loss surgery. one of those options is a procedure called a "laparoscopic sleeve gastrectomy" (lsg). in this procedure the majority of the patient's stomach is removed leaving behind a stapled "sleeve" about the same size as the patient's esophagus. during this procedure there are three main devices that surgeon inserts through the mouth and in to the stomach to calibrate the size of the "sleeve". they can use a standard weighted bougie, an endoscope, or a suction calibration device. this study aims to compare the difference in staple usage and post-operative gerd (heartburn) between patients that had an endoscope used versus patients that had a suction calibration system used on them during lsg.

Eligibility criteria:
inclusion criteria: * 18 years old or older * agreed with a surgeon that laparoscopic sleeve gastrectomy (lsg) is the best choice exclusion criteria: * had prior gastric surgery or bariatric surgery (including prior adjustable gastric band and/or sleeve gastrectomy) * concomitant hiatal surgery * paraesophageal hernia at time of surgery * any subject with prescribed immunosuppressive drugs. * in the opinion of investigator, subject is not eligible to participate in the study. * if patient is a female and becomes pregnant at any time during the study duration

Keywords: weight loss surgery laparoscopic sleeve gastrectomy suction calibration system bariatric surgery